Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach
Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling specific lots of the RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, item number 11-165304. The recall involves 7,428 units distributed worldwide, including the United States, Canada, and various international markets.
The recall was initiated because specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device. The affected lot number is 173500.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for the specific item number and lot number listed in this notice. If the product is found, it should be removed from use and returned to Biomet, Inc. according to their instructions.
The recalled product
- Product
- RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Const
- Manufacturer
- Biomet, Inc.
- Affected units
- 7,428
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 173500
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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